Statistical optimization applied to the HPLC determination of maprotilin

Abstract

A reversed-phase high performance liquid chromatographic method for the determination of maprotilin in bulk drugs, ampoules and tablets is described. To achieve maximum quantity, optimum conditions were used. In order to investigate the effect of each factor and their interaction a three variable, two-level, full-factorial design was chosen. A response-surface diagram was developed to identify the optimum experimental conditions. Maximum response was obtained on a Bondesil C18 column (5μm × 4.6mm × 250mm) with acetonitril-methanol (pH adjusted 4.5 with 0.1 mol/l CH3COOH) mobile phase (1:1, v/v ) and UV detection (λ.=272nm). Peak area responses were linearly related to concentrations of maprotilin in the range 4μg/ml-60μg/ml. The regression equation is y= -1.06574 + 564.095x with correlation coefficient r=0.996. The reliability of the proposed method was checked up at three different concentrations (RSD varied from 0.592 to 2.675%). The described method applied for the determination of maprotilin in tablets and ampoules gave precise and reproducible results; recovery was 98.61% for tablets and 98.92% for ampoules. The developed method can be recommended for the routine analysis of maprotilin in tablets and ampoules.